The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion
This study has been completed.
Sponsor:
Hospital Italiano de Buenos Aires
Information provided by:
Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT00978757
First received: September 16, 2009
Last updated: December 11, 2009
Last verified: October 2009
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Purpose
The purpose of this study is to determine whether ketamine is effective to inhibit interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatectomy |
Drug: Ketamine Other: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 4: Study of Ketamine Inhibition of Interleukin 6 in Hepatic Resections Requiring Temporary Porto-arterial Occlusion |
Resource links provided by NLM:
Further study details as provided by Hospital Italiano de Buenos Aires:
Primary Outcome Measures:
- The Effect of Ketamine on Interleukin 6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver) [ Time Frame: Blood samples for IL-6 levels were obtained prior to surgery, upon placement of the first intravenous ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | June 2001 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
|
Drug: Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
Other Name: Ketamine commercially available - FADA Pharma
|
|
Placebo Comparator: Placebo
Placebo: saline solution
|
Other: Placebo
saline solution
Other Name: Normal saline
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age: 21 or older
- Planned liver resection with Pringle maneuver lasting 30-60 minutes
Exclusion Criteria:
- Chronic illness requiring corticosteroids
- Cirrhosis
- Hemodynamic instability prior to surgery
- Diabetes
- Sepsis
- Surgical interventions or chemotherapy treatments within the past 30 days
- Pregnancy
- Illnesses that could potentially affect the hepatic circulation
- Arterial hypertension
- Ocular hypertension
- Allergy to ketamine
- Preoperative portal embolization
- Radiofrequency ablation
- Patients requiring emergency surgeries
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978757
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978757
Locations
| Argentina | |
| Hospital Italiano de Buenos Aires | |
| Ciudad Autonoma de Buenos Aires, Argentina, 1181 | |
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
| Principal Investigator: | Francisco C Bonofiglio, MD PhD | Hospital Italiano of Buenos Aires, Argentina |
More Information
No publications provided
| Responsible Party: | Hospital Italiano of Buenos Aires, Argentina, Hospital Italiano of Buenos Aires, Argentina |
| ClinicalTrials.gov Identifier: | NCT00978757 History of Changes |
| Other Study ID Numbers: | IRB#556 |
| Study First Received: | September 16, 2009 |
| Results First Received: | September 23, 2009 |
| Last Updated: | December 11, 2009 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Keywords provided by Hospital Italiano de Buenos Aires:
|
hepatectomy IL 6 organ failure ketamine Pringle |
Additional relevant MeSH terms:
|
Ketamine Analgesics Anesthetics Anesthetics, Dissociative Anesthetics, General Anesthetics, Intravenous Central Nervous System Agents Central Nervous System Depressants Excitatory Amino Acid Agents |
Excitatory Amino Acid Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015